|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03164018 |
|
Date of registration:
|
29/03/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Fampridine in MS Patients: A Cognition, Fatigue, Depression and Quality of Life Analysis
FAMILY |
|
Scientific title:
|
Fampridine in MS Patients: A Cognition, Fatigue, Depression and Quality of Life Analysis |
|
Date of first enrolment:
|
March 7, 2017 |
|
Target sample size:
|
111 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03164018 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Greece
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Adult patient (=18 years old) with MS.
- Patient receiving Fampyra® for walking disability (EDSS 4-7).
- Patient receiving stable doses of any Disease Modifying Treatment (DMT) for at least 3
months prior to study entry.
- Patients will receive Fampyra® in line with the approved Summary of Product
Characteristics (SmPC).
- Patients for whom the decision to prescribe therapy with Fampyra according to the
locally approved product's summary of product characteristics (SmPC) has already been
taken prior to their enrollment in the study and is clearly separated from the
physician's decision to include the patient in the current study.
- Patients must have signed an informed consent document.
- Patients must be able to read, understand and complete the study specific
questionnaires.
Exclusion Criteria:
- Pregnant or lactating woman.
- Patient with prior history or current presentation of seizure.
- Patient with mild, moderate or severe renal impairment (creatinine clearance < 80
ml/min).
- Concurrent treatment with other medicinal products containing fampridine
(4-aminopyridine).
- Concomitant treatment with medicinal products that are inhibitors of Organic
Transporter 2 (OCT2), e.g., cimetidine.
- Patients who have received more than 1 dose of fampridine at the time of enrollment
into the study.
- Patients that meet any of the contraindications to the administration of the study
drug according to the approved SmPC.
- Patients who currently receive treatment with any investigational
drug/device/intervention or have received any investigational product within 1 month
or 5 half-lives of the investigational agent (whichever is longer) before the
commencement of therapy with fampridine
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Multiple Sclerosis
|
|
Intervention(s)
|
|
Drug: Fampridine
|
|
Primary Outcome(s)
|
|
Changes in fatigue measured with MFIS scale
[Time Frame: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0).]
|
|
Changes in Quality of Life measured with MSIS-29 scale
[Time Frame: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0)]
|
|
Changes in cognition measured with PASAT scale
[Time Frame: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0).]
|
|
Changes in depression measured with BDI-II scale
[Time Frame: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0).]
|
|
Changes in Quality of Life measured with MusiQoL scale
[Time Frame: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0)]
|
|
Secondary ID(s)
|
|
NIS-GEN-FMP-001
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|